WO1999031218A1 - Sample-collecting and assay device - Google Patents
Sample-collecting and assay device Download PDFInfo
- Publication number
- WO1999031218A1 WO1999031218A1 PCT/GB1998/003669 GB9803669W WO9931218A1 WO 1999031218 A1 WO1999031218 A1 WO 1999031218A1 GB 9803669 W GB9803669 W GB 9803669W WO 9931218 A1 WO9931218 A1 WO 9931218A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- tube
- top part
- bottom part
- broken
- pieces
- Prior art date
Links
- 238000003556 assay Methods 0.000 title claims abstract description 7
- 239000007788 liquid Substances 0.000 claims abstract description 16
- 239000003153 chemical reaction reagent Substances 0.000 claims abstract description 12
- 238000006243 chemical reaction Methods 0.000 claims abstract description 10
- 239000012528 membrane Substances 0.000 claims abstract description 6
- 239000011888 foil Substances 0.000 description 5
- VFRROHXSMXFLSN-UHFFFAOYSA-N Glc6P Natural products OP(=O)(O)OCC(O)C(O)C(O)C(O)C=O VFRROHXSMXFLSN-UHFFFAOYSA-N 0.000 description 3
- 244000005700 microbiome Species 0.000 description 3
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 2
- 108010015776 Glucose oxidase Proteins 0.000 description 2
- 239000004366 Glucose oxidase Substances 0.000 description 2
- 108010001336 Horseradish Peroxidase Proteins 0.000 description 2
- 239000012491 analyte Substances 0.000 description 2
- 238000004458 analytical method Methods 0.000 description 2
- 239000008103 glucose Substances 0.000 description 2
- 229940116332 glucose oxidase Drugs 0.000 description 2
- 235000019420 glucose oxidase Nutrition 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 238000005086 pumping Methods 0.000 description 2
- 102000002281 Adenylate kinase Human genes 0.000 description 1
- 108020000543 Adenylate kinase Proteins 0.000 description 1
- NBSCHQHZLSJFNQ-GASJEMHNSA-N D-Glucose 6-phosphate Chemical compound OC1O[C@H](COP(O)(O)=O)[C@@H](O)[C@H](O)[C@H]1O NBSCHQHZLSJFNQ-GASJEMHNSA-N 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 102000030595 Glucokinase Human genes 0.000 description 1
- 108010021582 Glucokinase Proteins 0.000 description 1
- 230000003213 activating effect Effects 0.000 description 1
- UDMBCSSLTHHNCD-KQYNXXCUSA-N adenosine 5'-monophosphate Chemical compound C1=NC=2C(N)=NC=NC=2N1[C@@H]1O[C@H](COP(O)(O)=O)[C@@H](O)[C@H]1O UDMBCSSLTHHNCD-KQYNXXCUSA-N 0.000 description 1
- 230000029918 bioluminescence Effects 0.000 description 1
- 238000005415 bioluminescence Methods 0.000 description 1
- 230000000881 depressing effect Effects 0.000 description 1
- 230000000994 depressogenic effect Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 239000011363 dried mixture Substances 0.000 description 1
- 230000002255 enzymatic effect Effects 0.000 description 1
- 229940088598 enzyme Drugs 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 239000002207 metabolite Substances 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
- B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
- B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
- A61B10/0096—Casings for storing test samples
Definitions
- This invention relates to a sample-collecting and assay device, and in particular to a simple hygiene monitor. Background of the Invention
- WO-A-9425619 describes reactions where metabolites such as ATP can be amplified and detected, e.g. colorimetrically. Application of this chemistry is of value in dirt monitoring or in the detection of microorganisms on a surface that are collected by swabbing.
- WO-A-9525948 discloses a sample-collecting and assay device comprising a tube, a removable top part and a bottom part, wherein an elongate member with a swab at its distal end is mounted on the top part. There may be one or more foil-sealed bottom parts fixed within the tube, and the foils are successively broken by movement of the swab, or a coaxially-extending blade-like member, through the tube.
- WO-A-9703209 discloses a similar device, in which reagent is contained in a bottom part with a window, and which has a seal broken by movement of the swab through the tube. Another similar device is disclosed in WO-A-9723596. Summary of the Invention
- An assay device is for use in determining the presence in a liquid sample of a target component that, in combination with other components, undergoes a reaction to give a detectable signal.
- the novel device comprises a tube, a removable top part and a bottom part, wherein an elongate member with a swab at its distal end is mounted on the top part, the top part includes a compartment containing liquid and partly defined by a first frangible membrane that can be ruptured to release the liquid into the tube, and the bottom part contains a reagent and is partly defined by a second frangible membrane that can be ruptured on movement of the bottom part relative to the tube.
- the novel device shares many characteristics with the prior art devices, described above, its particular advantages include the use of a syringe-like mechanism within the top dispenser, to ensure repeatable and reproducible dispensing of liquid reagent.
- the top part may be unitary or comprise a separate component containing reagent, the design of the top reagent container and its holder may be such that a single operation, depressing the container, ruptures the seal and evacuates the contents of the container down the swab shaft, ensuring accurate and reproducible dispensing of the liquid reagent with minimal dead volume and without introduction of any air, unlike a "pumping" dispensing system.
- a device of this invention is particularly suitable for determining the presence of microorganisms, in which case the target component is ATP.
- the target component is ATP.
- the invention will now be described by way of example only with reference to this embodiment. Further, again for the purpose of illustration, the invention will be described with reference to reactions of the type described in WO-A-9425619, i.e. involving enzymes and their substrates. These materials constitute the components that, in combination, undergo the reaction that gives the detectable signal.
- Such a reaction includes the following: AMP + ATP - ADP
- G glucose
- G6P glucose-6-phosphate.
- Glucose is then converted to give a colour, in a further enzymatic sequence, e.g. utilising glucose oxidase (GO) and horseradish peroxidase (HRP).
- GO glucose oxidase
- HRP horseradish peroxidase
- the analyte may be detected by bioluminescence. Suitable reagents etc. are described in WO-A-9525428.
- the reaction components may be present together in the bottom part, in a freeze- dried mixture.
- a sample e.g. of microorganisms obtained by swabbing
- the reagents and liquid are mixed with them.
- the reaction generates a colour, comparison of that and a standard can be made readily, to give a quick indication of the concentration of the analyte in the sample.
- Figure 1 A shows separate side views of a device embodying the invention
- Figure IB is a cross-section of the same embodiment, along the line A-A in Fig. 1 A
- Figure 2 is an exploded view of the embodiment shown in Fig. 1.
- the embodiment illustrated there comprises a tube 1 with a pen-type holder 2.
- a top part 3 and a bottom part 4 are each mounted on the tube and each can be pushed into close engagement with the tube. In the case of the top part, close engagement is prevented, until required, by the removable or peelable safety seal 5.
- the top part 3 has mounted thereon a tubular elongate member 6 that terminates in a swab 7.
- the top part 3 also comprises a separate component 8 which is a compartment having a foil seal 9. On depression of this component, by a simple syringe action, without pumping, the foil seal is ruptured, and a known amount of liquid is discharged down the elongate member to the swab 7, within the tube 1.
- the top end of the elongate member is a sliding fit within the component 8.
- the bottom part 4 is in the form of a foil-sealed cuvette including a window 10. It may contain freeze-dried reagent(s).
- the foil is broken by pushing the part 4 inwardly with respect to the tube 1.
- the foil may be broken on the swab or on an angled bladelike member 11 provided as an internal component of the tube 1.
- the top part 3 is removed from the tube 1, a sample is taken up on the swab 7, and this is replaced in the tube.
- the seal on the bottom part 4 is then broken.
- the safety seal 5 is then removed, and the component 8 pushed inwards, to release a known quantity of liquid. Results can be read through the window 10.
- a qualitative assessment can be made by comparison of the colour generated with reference spots of different colour intensity (of which three are shown in Fig. 1 A).
- the proximal end of the elongate member 6 may be longer, so that it extends to a greater extent into the component 8, when that is depressed, so that there is a smaller residual volume. That volume may be accurately predetermined, e.g. 50 ⁇ L. That in turn ensures that for a given volume of liquid in the component 8, e.g. 500 ⁇ L, a predetermined amount is accurately dispensed, via the elongate member, to the swab.
- a further modification involves, instead of the seal 5, a frangible connection between the two pieces of the top part.
- the top part and the tube comprise means for their mutual location, e.g. a tongue and groove. It is also preferred that the frangible connection between the two pieces of the top part should be broken by relative rotation, i.e. in a sense different to that in which movement releases the liquid. This is also assisted by the mutual location of the top part and the tube.
- liquid i.e. extractant buffer
- simple shaking allows the sample to be removed from the swab as well as activating reagent in the bottom part. This assists the quantitative nature of the analysis.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Pathology (AREA)
- Hematology (AREA)
- Engineering & Computer Science (AREA)
- Analytical Chemistry (AREA)
- Clinical Laboratory Science (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
- Apparatus Associated With Microorganisms And Enzymes (AREA)
Abstract
Description
Claims
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU15692/99A AU1569299A (en) | 1997-12-16 | 1998-12-10 | Sample-collecting and assay device |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PCT/GB1997/003458 WO1998027196A1 (en) | 1996-12-16 | 1997-12-16 | Sample-collecting and assay device |
GBPCT/GB97/03458 | 1997-12-16 | ||
GBGB9813127.9A GB9813127D0 (en) | 1998-06-17 | 1998-06-17 | Sample-collecting and assay device |
GB9813127.9 | 1998-06-17 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1999031218A1 true WO1999031218A1 (en) | 1999-06-24 |
Family
ID=26311025
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/GB1998/003669 WO1999031218A1 (en) | 1997-12-16 | 1998-12-10 | Sample-collecting and assay device |
Country Status (2)
Country | Link |
---|---|
AU (1) | AU1569299A (en) |
WO (1) | WO1999031218A1 (en) |
Cited By (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6924498B2 (en) | 2002-04-24 | 2005-08-02 | Biocontrol Systems, Inc. | Sample collection and testing system |
US7030403B2 (en) | 2001-12-06 | 2006-04-18 | Biocontrol Systems, Inc. | Sample collection and bioluminescent sample testing system |
US7229783B2 (en) | 2000-08-01 | 2007-06-12 | Charm Sciences, Inc. | Method for monitoring hygiene |
WO2010129726A1 (en) * | 2009-05-06 | 2010-11-11 | 3M Innovative Properties Company | Articles with matrix comprising a cell extractant and biodetection methods thereof |
WO2010129727A1 (en) * | 2009-05-06 | 2010-11-11 | 3M Innovative Properties Company | Coated substrates comprising a cell extractant and biodetection methods thereof |
WO2011047902A1 (en) * | 2009-10-22 | 2011-04-28 | Gerhard Bonecker | Test set for a photometric measuring device and photometric measuring method for a sample liquid |
WO2010129728A3 (en) * | 2009-05-06 | 2011-04-28 | 3M Innovative Properties Company | Articles with shell structures including a cell extractant and biodetection methods thereof |
WO2013148524A1 (en) * | 2012-03-26 | 2013-10-03 | Alpha Tec Systems, Inc. | Specimen collection apparatus |
US9327284B2 (en) | 2004-01-21 | 2016-05-03 | Orion Diagnostica Oy | Sampling and assay device |
US9446406B2 (en) | 2012-06-29 | 2016-09-20 | Biocontrol Systems, Inc. | Sample collection and bioluminescent analysis system |
CN109477831A (en) * | 2016-07-20 | 2019-03-15 | 日本电气方案创新株式会社 | Target assay kit and target analysis method |
US20200278368A1 (en) * | 2017-09-27 | 2020-09-03 | Axxin Pty Ltd | Diagnostic test system and method |
US11634758B2 (en) | 2012-02-03 | 2023-04-25 | Axxin Pty Ltd | Nucleic acid amplification and detection apparatus and method |
Citations (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4178930A (en) * | 1977-10-31 | 1979-12-18 | Fisher Frank R Jr | Combined cap and needle structure |
US4353868A (en) * | 1981-05-29 | 1982-10-12 | Sherwood Medical Industries Inc. | Specimen collecting device |
US4508534A (en) * | 1981-12-02 | 1985-04-02 | Baxter Travenol Laboratories, Inc. | Assembly employing a breakable thermal bond which is not substantially effected by prolonged heat exposure |
US5084245A (en) * | 1988-11-07 | 1992-01-28 | Hygeia Sciences, Inc. | Assay device for swab borne analytes |
WO1993000994A1 (en) * | 1991-07-02 | 1993-01-21 | Amersham International Plc | Sampling device |
EP0538891A1 (en) * | 1991-10-25 | 1993-04-28 | Fujisawa Pharmaceutical Co., Ltd. | Infusion container |
WO1993012421A1 (en) * | 1990-12-13 | 1993-06-24 | Nason, Frederic, L. | Specimen test unit |
WO1995025948A1 (en) * | 1994-03-22 | 1995-09-28 | Celsis International Plc | Sample collecting and assay device |
WO1996014570A1 (en) * | 1994-11-07 | 1996-05-17 | Idexx Laboratories, Inc. | Self-contained signal generating sampling device and methods of use of same |
WO1997003209A1 (en) * | 1995-07-12 | 1997-01-30 | Charm Sciences, Inc. | Test apparatus, system and method for the detection of test samples |
WO1998027196A1 (en) * | 1996-12-16 | 1998-06-25 | Celsis International Plc | Sample-collecting and assay device |
-
1998
- 1998-12-10 WO PCT/GB1998/003669 patent/WO1999031218A1/en active Application Filing
- 1998-12-10 AU AU15692/99A patent/AU1569299A/en not_active Abandoned
Patent Citations (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4178930A (en) * | 1977-10-31 | 1979-12-18 | Fisher Frank R Jr | Combined cap and needle structure |
US4353868A (en) * | 1981-05-29 | 1982-10-12 | Sherwood Medical Industries Inc. | Specimen collecting device |
US4508534A (en) * | 1981-12-02 | 1985-04-02 | Baxter Travenol Laboratories, Inc. | Assembly employing a breakable thermal bond which is not substantially effected by prolonged heat exposure |
US5084245A (en) * | 1988-11-07 | 1992-01-28 | Hygeia Sciences, Inc. | Assay device for swab borne analytes |
WO1993012421A1 (en) * | 1990-12-13 | 1993-06-24 | Nason, Frederic, L. | Specimen test unit |
WO1993000994A1 (en) * | 1991-07-02 | 1993-01-21 | Amersham International Plc | Sampling device |
EP0538891A1 (en) * | 1991-10-25 | 1993-04-28 | Fujisawa Pharmaceutical Co., Ltd. | Infusion container |
WO1995025948A1 (en) * | 1994-03-22 | 1995-09-28 | Celsis International Plc | Sample collecting and assay device |
WO1996014570A1 (en) * | 1994-11-07 | 1996-05-17 | Idexx Laboratories, Inc. | Self-contained signal generating sampling device and methods of use of same |
WO1997003209A1 (en) * | 1995-07-12 | 1997-01-30 | Charm Sciences, Inc. | Test apparatus, system and method for the detection of test samples |
WO1998027196A1 (en) * | 1996-12-16 | 1998-06-25 | Celsis International Plc | Sample-collecting and assay device |
Cited By (21)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7229783B2 (en) | 2000-08-01 | 2007-06-12 | Charm Sciences, Inc. | Method for monitoring hygiene |
US7030403B2 (en) | 2001-12-06 | 2006-04-18 | Biocontrol Systems, Inc. | Sample collection and bioluminescent sample testing system |
US7399984B2 (en) | 2001-12-06 | 2008-07-15 | Biocontrol Systems Inc. | Sample collection and testing system having a displacement member causing reagent to come into contact with a sample collection surface |
US7544961B2 (en) | 2001-12-06 | 2009-06-09 | Biocontrol Systems, Inc. | Sample collection and testing system including a rotatable shaft with a helical guiding member to translate longitudinal motion of a slidable shaft into rotational motion |
US6924498B2 (en) | 2002-04-24 | 2005-08-02 | Biocontrol Systems, Inc. | Sample collection and testing system |
US9327284B2 (en) | 2004-01-21 | 2016-05-03 | Orion Diagnostica Oy | Sampling and assay device |
WO2010129726A1 (en) * | 2009-05-06 | 2010-11-11 | 3M Innovative Properties Company | Articles with matrix comprising a cell extractant and biodetection methods thereof |
WO2010129727A1 (en) * | 2009-05-06 | 2010-11-11 | 3M Innovative Properties Company | Coated substrates comprising a cell extractant and biodetection methods thereof |
WO2010129728A3 (en) * | 2009-05-06 | 2011-04-28 | 3M Innovative Properties Company | Articles with shell structures including a cell extractant and biodetection methods thereof |
US8906310B2 (en) | 2009-10-22 | 2014-12-09 | Gerhard Bonecker | Test set for a photometric measuring device and photometric measuring method for a sample liquid |
WO2011047902A1 (en) * | 2009-10-22 | 2011-04-28 | Gerhard Bonecker | Test set for a photometric measuring device and photometric measuring method for a sample liquid |
US11634758B2 (en) | 2012-02-03 | 2023-04-25 | Axxin Pty Ltd | Nucleic acid amplification and detection apparatus and method |
WO2013148524A1 (en) * | 2012-03-26 | 2013-10-03 | Alpha Tec Systems, Inc. | Specimen collection apparatus |
US9138747B2 (en) | 2012-03-26 | 2015-09-22 | Alpha Tec Systems, Inc. | Specimen collection apparatus |
US9403164B2 (en) | 2012-03-26 | 2016-08-02 | Alpha Tec Systems, Inc. | Specimen collection apparatus |
US10189020B2 (en) | 2012-03-26 | 2019-01-29 | Alpha Tec Systems, Inc. | Specimen collection apparatus |
US9446406B2 (en) | 2012-06-29 | 2016-09-20 | Biocontrol Systems, Inc. | Sample collection and bioluminescent analysis system |
US10684232B2 (en) | 2012-06-29 | 2020-06-16 | Biocontrol Systems, Inc. | Sample collection and bioluminescent analysis system |
CN109477831A (en) * | 2016-07-20 | 2019-03-15 | 日本电气方案创新株式会社 | Target assay kit and target analysis method |
US20200278368A1 (en) * | 2017-09-27 | 2020-09-03 | Axxin Pty Ltd | Diagnostic test system and method |
US11709175B2 (en) * | 2017-09-27 | 2023-07-25 | Axxin Pty Ltd | Diagnostic test system and method utilizing a closure/sample dispensing mechanism to dispense a sample subvolume for testing |
Also Published As
Publication number | Publication date |
---|---|
AU1569299A (en) | 1999-07-05 |
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